The following data is part of a premarket notification filed by Design Standards Corp. with the FDA for Sureline Laparoscopic Clip Applier With Implantable Titanium Clips.
| Device ID | K040602 |
| 510k Number | K040602 |
| Device Name: | SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
| Classification | Clip, Implantable |
| Applicant | DESIGN STANDARDS CORP. 182 CEDA RD. P.O. BOX 1620 Charlestown, NH 03603 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey DESIGN STANDARDS CORP. 182 CEDA RD. P.O. BOX 1620 Charlestown, NH 03603 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-05-10 |
| Summary: | summary |